Valerian composition and related methods

Abstract

A valerian composition includes valerian and an acidifying agent blended together in a pharmaceutically acceptable hydrogel-forming polymer matrix. An expedited release portion of the dosage form includes 5% to 50% of the valerian and is effective to release the valerian therein within 2 hours from placement in a 0.1 N HCl solution. A sustained release portion of the dosage form includes the remainder of the valerian and is effective to release the valerian therein within 10 hours from placement in a phosphate buffer with a pH of 6.8.

That which is claimed is: 
     
       1. A composition comprising a therapeutically effective oral pharmaceutical dosage form including valerian within an acidified polymer matrix, the acidified polymer matrix including an acidifying agent and a hydrogel-forming polymer blended together, the acidifying agent being in an amount sufficient to impart a pH of 2 to 5 to the acidified polymer matrix;
 the acidifying agent including at least one acid selected from the group consisting of citric acid, succinic acid, tartaric acid, phosphoric acid, and hydrochloric acid; 
 the hydrogel forming polymer including at least one polymer selected from the group consisting of a carboxymethylcellulose, a methylcellulose, a hydroxypropylcellulose, a hydroxypropylmethylcellulose, a hyaluronate, an alginate, a pectin, a poloxamer, a poloxamine, an ethylene vinyl acetate, a polyethylene glycol, a dextran, a polyvinylpyrrolidone, a chitosan, a polyvinylalcohol, a propylene glycol, a polyvinylacetate, a polylactic acid, and a polyhydroxybutyric acid; 
 an expedited release portion of the pharmaceutical dosage form including 5% to 50% of the valerian in the pharmaceutical dosage form, the expedited release portion being effective to release the valerian therein within 2 hours from placement in a 0.1 N HCl solution; and 
 a sustained release portion of the pharmaceutical dosage form including a remainder of the valerian in the pharmaceutical dosage form, the sustained release portion being effective to release the valerian therein from at least 2 to within 10 hours from placement in a phosphate buffer with a pH of 6.8 wherein the amount of acidifying agent makes the pharmaceutical dosage form storage stable by reducing degradation of the valerian when the pharmaceutical dosage form is stored at 25 degrees C. and 60% relative humidity. 
 
     
     
       2. The composition of  claim 1 , wherein the amount of acidifying agent is sufficient to impart a pH of 3 to 5 to the acidified polymer matrix. 
     
     
       3. The composition of  claim 1 , wherein the pharmaceutical dosage form is at least one oral dosage form selected from a tablet, capsule, and a multiparticulate. 
     
     
       4. The composition of  claim 1 , wherein the pharmaceutical dosage form includes 150 mg to 250 mg of valerian. 
     
     
       5. The composition of  claim 1 , wherein:
 valerian is 15% w/w to 45% w/w of the pharmaceutical dosage form; 
 the acidifying agent is 1% w/w to 20% w/w of the pharmaceutical dosage form; and 
 the hydrogel-forming polymer is 1% w/w to 15% w/w of the pharmaceutical dosage form. 
 
     
     
       6. The composition of  claim 1 , wherein the acidifying agent is citric acid and the hydrogel-forming polymer is hydroxypropyl methylcellulose.